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PASS LP Spinal System B02516540

by Medicrea International SA

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03613720295334 UDI-DI Date24 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK190376 Date2 May 2019IssuedStatusActive

Recalls

7 recalls · 3 ongoing · FDA

    • Ongoing Z-2458-2023 FDA Class II initiated 12 Jul 2023 on shared 510(k) K110497

    There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

  • 2 recalls, same reason

    • Ongoing Z-0827-2020 FDA Class II initiated 16 Sep 2019
    • Ongoing Z-0828-2020 FDA Class II initiated 16 Sep 2019

    Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

  • 2 recalls, same reason

    • Terminated Z-1473-2020 FDA Class II initiated 28 Jan 2020
    • Terminated Z-1472-2020 FDA Class II initiated 28 Jan 2020

    An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.

    • Terminated Z-1234-2020 FDA Class II initiated 11 Nov 2019 on shared 510(k) K190376

    Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)

    • Terminated Z-0753-2020 FDA Class II initiated 27 Jun 2019 on shared 510(k) K141398

    It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum area. As a result, a screw that is too long could come into contact with the nerves and cause postoperative pain.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k) · GUDID

Trade Name
Pass LP Spinal System
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Reference
B02516540
Primary DI / UDI-DI
03613720295334
510(k) Number
FDA Product Code
KWP
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3050
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PASS LP Spinal System B02516540 is a spinal bone screw, non-bioabsorbable, designed as a small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation. It is screwed into the spine to hold a correction or stabilization device such as a rod, plate, or tether to bone, providing immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities.

This device is supplied non-sterile and requires sterilization prior to use via moist heat or steam sterilization. It is intended for single-use only, requires a prescription, and is not a kit. The device does not contain MRI safety information in its labeling and has no expiration date. It is identified by model number B02516540 and is currently in commercial distribution.

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K153413)

Show all (12)

Other devices from Medicrea International SA

See all devices from Medicrea International SA →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Is the PASS LP Spinal System B02516540 sterile when supplied?

    No, the device is not sterile when supplied. The specifications indicate is_sterile=false, meaning it requires sterilization prior to use.

  • What sterilization method is recommended for the PASS LP Spinal System B02516540?

    The device must be sterilized prior to use using moist heat or steam sterilization, as specified in the sterilization_methods field.

  • Can the PASS LP Spinal System B02516540 be used more than once?

    No, the device is designated for single-use only, as indicated by is_single_use=true in the specifications.

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

  • Sterile: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No